Trial Outcomes & Findings for Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients (NCT NCT06223373)
NCT ID: NCT06223373
Last Updated: 2025-11-04
Results Overview
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
TERMINATED
NA
3 participants
Baseline
2025-11-04
Participant Flow
Participant milestones
| Measure |
Blood Flow Restriction (BFR)
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
"Sham" Blood Flow Restriction (BFR)
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Blood Flow Restriction (BFR)
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
"Sham" Blood Flow Restriction (BFR)
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients
Baseline characteristics by cohort
| Measure |
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 0 • n=15 Participants
|
41.5 years
STANDARD_DEVIATION 10.6 • n=161 Participants
|
42.3 years
STANDARD_DEVIATION 7.6 • n=100 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Baselinemeasuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
|
13.1 ft-lb (pound foot)
Standard Deviation 8.3
|
28.6 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
|
19.2 ft-lb (pound foot)
Standard Deviation 0
|
23.2 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineLow Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
|
11.1 ft-lb (pound foot)
Standard Deviation 5.9
|
19.0 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
|
13.9 ft-lb (pound foot)
Standard Deviation 0
|
16.6 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineLow Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
|
7.0 ft-lb (pound foot)
Standard Deviation 0.28
|
14.4 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
|
13.6 ft-lb (pound foot)
Standard Deviation 0
|
11.2 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineLow Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
|
11.0 ft-lb (pound foot)
Standard Deviation 9.5
|
23.2 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
|
9.9 ft-lb (pound foot)
Standard Deviation 0
|
27.2 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineLow Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
|
15.6 ft-lb (pound foot)
Standard Deviation 7.8
|
23.5 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
|
7.6 ft-lb (pound foot)
Standard Deviation 0
|
26.7 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineLow Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
|
14.5 ft-lb (pound foot)
Standard Deviation 2.3
|
23.5 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
Low Score indicates low torque/strength, high score indicates high torque/strength
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
|
6.6 ft-lb (pound foot)
Standard Deviation 0
|
26.6 ft-lb (pound foot)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineUltrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
|
7.29 cm2
Standard Deviation 1.23
|
10.04 cm2
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 3Population: Patient elected to do PT at home and was lost to follow up
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
|
6.33 cm2
Standard Deviation 0
|
10.15 cm2
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Patient elected to do PT at home and was lost to follow up
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
|
6.48 cm2
Standard Deviation 0
|
10.34 cm2
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineUltrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
|
11.48 cm2
Standard Deviation 0.24
|
11.84 cm2
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 3Population: Patient elected to do PT at home and was lost to follow up
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
|
11.24 cm2
Standard Deviation 0
|
11.89 cm2
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Patient elected to do PT at home and was lost to follow up
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
|
11.76 cm2
Standard Deviation 0
|
12.33 cm2
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselinePopulation: 1 patient did not have any data collected at this field
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Visual Analog Scale (VAS) for PAIN - Baseline Scores
|
5 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Patient elected to do PT at home and was lost to follow up
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Visual Analog Scale (VAS) for PAIN - Week 6 Scores
|
4 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Month 6Population: 1 patient elected to do PT at home and 1 patient had surgery
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Visual Analog Scale (VAS) for PAIN - Month 6 Scores
|
—
|
0 Score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Month 12Population: All patients lost to follow up, value never collected
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselineThe American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Baseline Scores
|
42.5 score on a scale
Standard Deviation 6.6
|
73 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Patient elected to do PT at home and was lost to follow up
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Week 6 Scores
|
42 score on a scale
Standard Deviation 0
|
95 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Month 6Population: 2 Sham patients lost to follow up and measure was never reported or collected.
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 6 Scores
|
—
|
100 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Month 12Population: Patient lost to follow up, value never collected -Patient lost to follow up, value never collected
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselineThe DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=2 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Baseline Scores
|
62.6 score on a scale
Standard Deviation 27.4
|
35.5 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 6Population: Patient elected to do PT at home and was lost to follow up
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
n=1 Participants
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Week 6 Scores
|
68.4 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Month 6Population: 2 Sham patients lost to follow up and measure was never reported or collected.
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Outcome measures
| Measure |
"Sham" Blood Flow Restriction (BFR)
rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
"sham" Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
|
Blood Flow Restriction (BFR)
n=1 Participants
Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
|
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 6 Scores
|
—
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Month 12Population: Patient lost to follow up, value never collected - Patient lost to follow up, value never collected
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 3Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 6Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 3Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 6Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 3Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 6Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Outcome measures
Outcome data not reported
Adverse Events
Blood Flow Restriction (BFR)
"Sham" Blood Flow Restriction (BFR)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kristen Faith Nicholson, PhD
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place